Translate Title: Evaluation of the Efficacy of Two Guidance Techniques (Standard Injected CT vs Porto-scanner With Angio-CT) for Thermoablation Treatment of Colorectal Cancer Liver Metastases: Randomized, Single-blind, Controlled Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Hepatic metastases of colorectal cancer (CRC) are partially necrotic tumors mainly vascularized by the hepatic artery. When resectable, these metastases must be removed with a safety margin of 1 mm. Resection margins greater than 1 cm are associated with better disease-free survival and no local recurrence. Thermoablation systems allow for ablation zones of approximately 4.5-5 cm in diameter. For tumors \<3 cm, subject to perfect targeting, it is possible to obtain ablation margins of 1 cm, which would greatly reduce the local recurrence rate. Accurate assessment of these tumor boundaries and characterization of these margins are paramount to ensure complete ablation. Thermoablation for these small liver metastases (\<3cm) has shown equivalent efficacy to surgery in terms of recurrence and survival with fewer complications. Thermoablation treatment is indicated for patients with stable disease undergoing chemotherapy. This leads to liver remodeling and metastases become difficult to see on ultrasound and CT scans. The study authors hypothesize that the porto-scanner guidance technique with Angio-CT for thermoablation treatment of CRC liver metastases will allow a better exploration of these metastases by allowing a better identification of the margins and thus ensure a more accurate and complete treatment for patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The patient must have given their free and informed consent and signed the consent form

• The patient must be a member or beneficiary of a health insurance plan

• Patients with CRC liver metastases (\< 3 lesions, \< 3 cm in diameter), proven on MRI and/or Positron Emission Tomography scan.

• Patient eligible for thermoablation requiring CT guidance (at least one metastasis not visible on ultrasound).

• Treatment by thermoablation validated in multidisciplinary meeting.

• Eastern Cooperative Oncology Group performance score 0-2.

• ASA score 1-3.

• Life expectancy of more than 3 months.

• Renal function allowing iodinated contrast injection (clearance \> 30 mL/min), normal liver function (bilirubin \< 35 µmol/L) and hemostasis assessment allowing percutaneous procedure (PT \> 50%, platelets \> 50 G/L, anticoagulant treatment to be stopped).

• Postmenopausal patient or patient with effective contraception (hormonal or mechanical)

• Pregnancy test (bHCG blood) negative in the month prior to inclusion for patients of childbearing age

‣ Patients with a history of radical treatment (surgery, radiofrequency or stereotactic radiotherapy) for liver metastases more than 6 months old.

⁃ Patient presenting a recurrence at a distance from the treated lesion (more than 1 cm from the scar).

Locations
Other Locations
France
CHU de Montpellier
RECRUITING
Montpellier
CHU de Nîmes
NOT_YET_RECRUITING
Nîmes
Contact Information
Primary
Julien Frandon
julien.frandon@chu-nimes.fr
04.66.68.67.22
Time Frame
Start Date: 2023-01-31
Estimated Completion Date: 2026-09
Participants
Target number of participants: 88
Treatments
Active_comparator: Control
Experimental: Porto-scanner guidance with Angio-CT
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nīmes

This content was sourced from clinicaltrials.gov